FDA 483 - Aphena Pharma Solutions - Tennessee LLC - October 15, 2021

An FDA inspection of Aphena Pharma Solutions - Tennessee LLC in Cookeville, TN, a drug packager, identified two significant observations. The firm failed to exercise strict control over drug product labeling, lacking a secured storage area and written procedures for labeling transfer and use. Additionally, packaging equipment was not appropriately qualified across the full range of container and closure sizes for specific drug products.